Impact of Increased Water Intake in Chronic Kidney Disease

NCT01766687 | Completed DMC

• 1 other identifier: S-London RCT
• Study Type: interventional
• Target: 822
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have designed a randomized controlled trial to test whether increased water intake slows renal decline in patients with Stage-III Chronic Kidney Disease. Participants randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 L of water per day (depending on sex and weight), in addition to usual fluid intake, for one year. The investigators will calculate the change in kidney function (estimated glomerular filtration rate, measured every three months for 12 months), and compare renal decline between the intervention and control groups. The investigators hypothesize that increased water intake will slow renal decline.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; estimated glomerular filtration rate; water intake; fluid intake; renal decline

Outcome Measures

Primary Outcomes (1)

• Renal decline

  Change in estimated glomerular filtration rate between baseline and 12 months

  Baseline and 12 months

Secondary Outcomes (5)

• 24-hour urine albumin

  Baseline and 12 months

• Rapid renal decline

  Baseline and 12 months

• Measured creatinine clearance

  Baseline and 12 months

• Health-related quality of life

  Baseline and 12 months

• Copeptin

  Baseline and 12 months

Other Outcomes (5)

• Body Mass Index

  Baseline and 12 months

• Blood pressure

  Baseline and 12 months

• HbA1c

  Baseline and 12 months

Study Arms (2)

Hydration

EXPERIMENTAL

Participants randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 L of water per day (depending on sex and weight), in addition to usual consumed beverages, for 12 months.

Dietary Supplement: Hydration

Control

NO INTERVENTION

Interventions

Hydration DIETARY_SUPPLEMENT

Hydration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Able to provide informed consent and willing to complete follow-up visits.
• Estimated glomerular filtration rate between 30 and 60 ml/min/1.73m2
• Trace protein or greater (Albustix) or urine albumin/creatinine ratio \>2.8 mg/mmol (if female) or \>2.0 mg/mmol (if male) from a random spot urine sample

You may not qualify if:

• Self-reported fluid intake \>10 cups/day or 24-hr urine volume \>3L.
• Enrolled in another trial that could influence the intervention, outcomes or data collection of this trial (or previously enrolled in this trial)
• Received one or more dialysis treatments in the past month
• Kidney transplant within past six months (or on waiting list)
• Pregnant or breastfeeding
• History of kidney stones in past 5 years
• Less than two years life expectancy
• Serum sodium \<130 mEq/L without suitable explanation
• Serum calcium \>2.6 mmol/L without suitable explanation
• Currently taking hydrochlorothiazide \>25 mg/d, indapamide \>1.25 mg/d, furosemide \>40 mg, or metolazone \>2.5 mg/d
• Currently taking lithium
• Patient is under fluid restriction (\<1.5 L a day) for kidney disease, heart failure, or liver disease, AND meets any of the following criteria: i) end stage of the disease (heart left ventricular ejection fraction \<40%, NYHA class 3 or 4, or end stage cirrhosis) or ii) hospitalization secondary to heart failure, ascites and/or anasarca
• Patient has GI disease (history of inflammatory bowel disease, Crohns, etc.)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Related Publications (4)

• Clark WF, Huang SH, Garg AX, Gallo K, House AA, Moist L, Weir MA, Sontrop JM. The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial. Can J Kidney Health Dis. 2017 Aug 22;4:2054358117725106. doi: 10.1177/2054358117725106. eCollection 2017.

  PMID: 28856009 BACKGROUND

• Moist LM. Can Additional Water a Day Keep the Cysts Away, in Patients with Polycystic Kidney Disease? NEJM Evid. 2022 Jan;1(1):EVIDe2100027. doi: 10.1056/EVIDe2100027. Epub 2021 Nov 4.

  PMID: 38320097 DERIVED

• Clark WF, Sontrop JM, Huang SH, Gallo K, Moist L, House AA, Cuerden MS, Weir MA, Bagga A, Brimble S, Burke A, Muirhead N, Pandeya S, Garg AX. Effect of Coaching to Increase Water Intake on Kidney Function Decline in Adults With Chronic Kidney Disease: The CKD WIT Randomized Clinical Trial. JAMA. 2018 May 8;319(18):1870-1879. doi: 10.1001/jama.2018.4930.

  PMID: 29801012 DERIVED

• Roussel R, Velho G, Bankir L. Vasopressin and diabetic nephropathy. Curr Opin Nephrol Hypertens. 2017 Jul;26(4):311-318. doi: 10.1097/MNH.0000000000000335.

  PMID: 28403013 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William F Clark, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research staff and participants were aware of the randomized group assignment; however, outcome assessors (technicians performing the laboratory measurements for the primary and secondary outcomes) are blinded to the random allocation, and the trial statistician will be blinded to patient allocation for the primary analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 11, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

CA (1)